FDA GIVES NDMA GREEN LIGHT TO BEGIN ATTAPULGITE, PPA STUDIES
This article was originally published in The Tan Sheet
Executive Summary
FDA GIVES NDMA GREEN LIGHT TO BEGIN ATTAPULGITE, PPA STUDIES in two letters sent to the association in June. However, while the Nonprescription Drag Manufacturers Association and FDA are in agreement on the final protocol for the phenylpropanolamine study, FDA recommended several changes in the attapulgite protocol related to efficacy endpoints.